Z-2018-2017 Class II Terminated
FDA device recall Z-2018-2017 was initiated by The Anspach Effort, Inc. on Oct 6, 2016 and is designated Class II. Reason for recall: Supplied Directions for Use (DFU) did not contain a recommended service interval. The recall status is terminated (terminated Jul 26, 2019).
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2017
- Initiation Date
- Oct 6, 2016
- Termination Date
- Jul 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
90 degree Contra Angle Attachment Product Usage: Pneumatic system
Reason for Recall
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Code Information
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-90.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2018-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026